Covidien receives CE Mark approval for Stellarex drug-coated balloon

Covidien has announced that its Stellarex drug-coated angioplasty balloon has been granted European CE Mark approval.

The device is designed to restore and maintain blood flow to the arteries of the leg in patients with peripheral arterial disease. Its efficacy has been demonstrated over 24 months in the recent Illumenate First-in-Human (FIH) study.

Stellarex can be inserted into diseased arteries and inflated to open the vessel and restore blood flow, while the drug paclitaxel is deposited on to the vessel wall to prevent the reoccurrence of new blockages.

Its EnduraCoat technology provides a durable and uniform coating to minimise drug loss during transit and facilitate efficient drug delivery to the treatment site.

Illumenate FIH principal investigator Dr Henrik Schroeder, a radiologist at the Vascular Center-Jewish Hospital in Berlin, said: "Drug-coated balloons are emerging as an alternative to traditional treatment options, such as angioplasty or stenting, because of their ability to restore blood flow, prevent the reoccurrence of new blockages and preserve future treatment options."

Covidien will soon sell off the Stellarex business to Spectranetics, a deal that has been agreed under the terms of its imminent merger with Medtronic.